CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction) (CAPTURE)

Cardio and Atherosclerosis Prevention and Treatment Via Fat Uptake REduction With a Specified Biopolymer: One Year Randomized Double-blind Placebo-controlled Clinical Investigation to Improve Vascular Health in Patients at Cardiovascular Risk: CAPTURE Study (Polyglucosamine for Cardio & Atherosclerosis Prevention and Treatment Via Fat Uptake REduction)

This clinical investigation is intended to confirm the application of a new intended purpose and a new indication for an already certified medical device. Therefore, it is a pivotal clinical investigation with a confirmatory type of design.

Study Overview

• Status: Not yet recruiting
• Conditions: Atherosclerotic Disease
• Intervention / Treatment: Device: Placebo; Device: Polyglucosamine

Detailed Description

Background and rationale The Investigational Product (formoline AtheroGuard, main ingredient: customized Polyglucosamine) administered by oral route before main meals binds fats in the stomach and intestine simply by physicochemical reaction and reduces their absorption and hydrolysis. The lower fat availability stimulates the mobilization of reserve lipids to be used for the metabolic processes and reduce the inflammatory cascade that can activate reactive cells (macrophages) in triggering atherosclerosis. Clinical data: Polyglucosamine treatment for 2 years significantly reduced Carotid Intima Media Thickness (CIMT). A recent meta-analysis has suggested a positive association between the progression of the Intima-Media Thickness (IMT) and cardiovascular risk. The results showed that interventional effects on the Carotid Intima-Media Thickness (CIMT) are also likely to reduce CV event rates.

Objective(s) The primary objective is to reduce or stabilize the increase of the arterial CIMT.

The reduction of plaque area, the change in plaques deposits, body weight, abdominal circumference, BMI, blood pressure, blood glucose, insulin resistance, insulin blood levels, hsCRP, oxidative stress, and the improvement of the lipid profile (reduction of triglycerides, total cholesterols, LDL and increase of HDL) are considered secondary objectives.

The safety objectives are to demonstrate the safety of formoline AtheroGuard 750 mg tablets administered for 12 months Design Two arms multicenter randomized double-blind placebo controlled clinical investigation

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • University Gabriele d'Annunzio Chieti - Pescara
    • Contact: Beatrice Feragalli, Prof; Phone Number: 00398713551; Email: beatrice.feragalli@unich.it
    • Contact: Beatrice Feragalli, Prof
  • Perugia, Italy, 06129
    • S. Maria della Misericordia Hospital
    • Contact: Matteo Pirro, Prof; Phone Number: 0039755784020; Email: matteo.piro@unipg.it
    • Contact: Matteo Pirro, Prof
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Pisa University Hospital - Clinical Research Unit
      • Contact: Stefano Masi, Prof; Phone Number: 0039-50995732; Email: stefano.masi@unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Outpatients of both genders, with CIMT > 1.00 mm suffering from hypertension and/or type II diabetes and/or hypercholesterolemia, under stable treatment for these conditions since at least 6 months.
• Age between 45-65
• BMI > 26 ≤35
• Total cholesterol ≥ 200 ≤ 240 mg/dL
• BP mm Hg: Mx ≥ 135 ≤ 160 ; Mn ≥ 75 ≤ 90 the subject must remain 10 min at rest in clinostatic position before measurement
• Blood glucose Mn ≥ 80 ; Mx ≤ 130 mg/dL
• The subjects suffering from hypertension, and/or diabetes, and/or hypercholesterolemia can be admitted provided that the diseases under chronic treatment are mitigated with no more than 2 drugs. By drug we mean any formulation (in tablets, capsules, fluid etc..) containing one or more active ingredients. This therapy has to be administered 4 hours before or after the product under evaluation.
• ESC score (European Society of Cardiology) < 10
• Informed consent must be obtained prior to participation.
• Subjects able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
• Subjects must be willing and able to give informed consent/assent for participation in the study.
• Negative pregnancy test for women with childbearing capacity.

Exclusion criteria

• Age < 45 or > 65 years.
• Pregnancy or breastfeeding. During the study, women of reproductive age will have to use reliable contraceptive methods.
• Mx BP > 160 Mn > 90 despite a treatment of 6 months with common antihypertensive
• Total cholesterol > 240 mg/dL despite a treatment of 6 months with the common hypolipemic drugs
• Morning blood glucose > 130 mg/dL despite a treatment of 6 months with common oral hypoglycemic drugs
• BMI > 35
• ESC score (European Society of Cardiology) ≥ 10
• Myocardial infarction
• Neurological disorders
• Cancer
• Gout
• Kidney dysfunction (creatinine > 3 mg/dl)
• Liver dysfunction (ALT > 40 U/L)
• COPD (FEV < 80% of predicted value)
• Psychiatric diseases
• IBS
• Anemia (HB < 10 g/dl)
• Inability or unreliability of the Food Intake Assessment [4]
• Hypersensitivity to polyglucosamine
• Any medical condition or abnormality of clinical laboratory tests that needs systemic pharmacological treatment besides treatment for hypertension, type II diabetes or hypercholesterolemia. This means that local treatments will be allowed.
• Vulnerable subjects: incapacitated, immunocompromised, or other conditions which may bring to a condition of vulnerability.
• Subjects under emergency circumstances
• Treatment with orally applicable drugs exceeding application in the morning and in the late evening
• Current treatment with GLP-1 agonists, fosinopril, acarbose.
• In the case of treatment with food supplements the subject can be enrolled after 1 month of product withdrawal.
• Known allergy to crustaceans or one of the ingredients
• Chronic constipation
• Intestinal obstruction
• Intake of long-term medications that significantly slow down intestinal activity
• Current participation in any other investigational trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo consists of tablets	Device: Placebo; 2x 2 Placebo tablets The treatment will continue for 12 months administering Placebo (twice/day) before the two main meals for a total of 4 tabs/day. Controls will be conducted at screening/baseline, and after 3/6/9 and 12 months
Experimental: Device; 750 mg tablets main ingredient Polyglucosamin	Device: Polyglucosamine; The treatment will continue for 12 months administering a customized Polyglucosamine (formoline AtheroGuard) (twice/day) before the two main meals for a total of 4 tabs/day (each tab consists of 750 mg). Controls will be conducted at screening/baseline, and after 3/6/9 and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint of the study is the reduction or stabilization of CIMT progression (measured through ultrasound)	To demonstrate the benefit of formoline AtheroGuard reducing or stabilizing CIMT and plaques volume in patients suffering from dyslipidemia, hypertension, or type II diabetes.	Screening visit/baseline; after 6 months; after 12 months of treatment

Collaborators and Investigators

• Sponsor: Certmedica International GmbH
• Collaborators: Evidilya S.r.l.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: CAPTURE formoline AtheroGuard
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: CIV-IT-24-07-048534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No